510(k) K904085 ยท KCZ Prosthesis, Breast, External, Used With Adhesive
ELLA BREAST FORM
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Oct 31, 1990 |
| Received | Sep 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904085
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.